Kornimate/medical-research-clean huggingface dataset:
tens for suction evacuation for termination of 1st trimester pregnancies

Conditions: Pregnancy, Abdominal; Termination of Pregnancy; Pain, Nerve

Summary: to study the effectiveness of the pain relief method of transcutaneous electrical nerve stimulation (tens) for women who will undergo suction evacuation under conscious sedation for first trimester termination of pregnancy.

suction evacuation is a minor gynecological procedure commonly performed at an outpatient setting for termination of pregnancy. although it is a simple surgical procedure lasting 5-10 min and can be done under various methods of pain control, 78-97% of women still report at least moderate procedural pain, especially during injection of paracervical block, cervical dilation, suction aspiration and postoperatively with uterine cramping. in addition, those pharmacological analgesic methods are often associated with numerous adverse effects and cannot be applicable to all women. the transcutaneous nerve stimulation (tens) method is commonly used to treat labour pain. it is an inexpensive, quick, easy to use and noninvasive pain relief method. a recent study by lison et al. on tens for office hysteroscopy demonstrated a significant decrease in pain scores when compared to control and placebo groups. the rationale of tens lies in achieving pain reduction when electric stimulation alters the nociceptive transmission in the dorsal horn of the spinal cord; this means the electrode has to be adequately applied in the right receptive field of the body to achieve pain control. for the setting of tens there is evidence supporting superior pain relief by random high frequencies tens over fixed frequency. increasing the pulse duration to above 250 microseconds also produces better analgesics effect. in suction evacuation, the nerve roots of t10-l1 and s2-s4 becomes relevant as they correspond to the nerve supply to the whole uterus and cervix. lison et al placed electrodes at these levels parallel to the spinal cord in their study and have instructed their subjects to increase the tens intensity to the maximum nonpainful level, allowing further increase when their stimulus perception decrease as a result of nerve accommodation. its use in suction evacuation however, remains undetermined as there is no published study in this area.

Eligibility criteria:
inclusion criteria: * chinese aged 18 years or above and mentally competent * up to 12 weeks gestation on the day of stop * size of the uterus on pelvic examination compatible with estimated duration of pregnancy, or dating confirmed with ultrasound scan * normal general and gynecological examination exclusion criteria: * skin damage or allergy at site of tens pads application * previous experience with tens * history of pacemarker insertion * history of severe respiratory or cardiac disease * severe and recurrent liver disease * allergic to lignocaine * myasthenia gravis * psychiatric conditions requiring medication * disorders that constitute contraindications to use of prostaglandins

Keywords: tens pain relief stop surgical abortion
dermacyd ph_desilsty_fl (lactic acid) - photo evaluation - stay on floral

Conditions: Hygiene

Summary: primary objective: to demonstrate the absence of photoirritation and photosensitization potential of the product dermacyd phdesilstyfl. secondary objective: none.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii integral skin test in the region * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or pregnancy * use of antiinflammatory 30 days and/or immunossupression drugs for until 03 months before volunteers selection * use of antihistamines 30 days before selection * disease which can cause immunosuppresion, such as diabetes, hiv * use of photosensitivity drugs * history of sensitivity or photosensitivity for topic products * cutaneous active disease which can modify the study results * history or activity of photodermatosis * personal or family antecedents of cutaneous neoplasia photo induced * presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis * intense exposure solar in the test region * use of new drugs and/or cosmetics during the study * previous participation in studies using the same product in test * relevant history or confirmation of alcohol or other drugs abuse * intolerance detected or suspected for some component of the sample tested * medecin or sponsor employees or their close family. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
community-based occupational therapy intervention on mental health for people with acquired brain injury

Conditions: Acquired Brain Injury; Mental Health Issue

Summary: the main purpose of this research project is to analyze the effectiveness of a community-based occupational therapy intervention on mental health for people with acquired brain injury. to this end, variables such as quality of life, occupational performance and balance, participation in significant roles and community integration will be measured. the research will be carried out as a non-randomized controlled trial study in which the participants in the experimental arm will receive a community-based occupational therapy intervention (domiciliary and telehealth intervention sessions) based on the stages of the human occupation model's remotivation process. the participants at the control arm will receive the regular (public or private) services provision for this population profile. it is expected to be able to demonstrate the effectiveness of the intervention based on a positive result in the change in the variables, so as to increase the chance and performance of occupational participation after the acquired brain injury. also, it is intended that families and the community are key elements of agency and support in occupational participation.


Eligibility criteria:
inclusion criteria: adults with a diagnosis of medium or severe abi and a diagnosis of neurocognitive disorder following abi (as recognised in the 5th edition of the diagnostic and statistical manual of mental disorders (dsm-5); by definition: evidence of significant cognitive decline from pre-abi level in one or more cognitive domains (attention, executive function, learning and memory, perceptual-motor ability or social cognition). it may occur with or without behavioural impairment (apathy, mood disturbance, irritability, disinhibition, psychotic symptoms, etc.)). this population (a) show difficulties in occupational participation with respect to the pre-abi situation and present needs for support, counselling and/or specific therapeutic intervention; (b) are in a situation of hospital discharge from abi specialisation units; (c) are domiciled in the same province to which the providing hospital belongs. in addition, they may or may not have been diagnosed with a mental health disorder other than neurocognitive disorder, either prior or subsequent to the abi. exclusion criteria: persons will be excluded if (a) they are in a situation of symptomatological destabilisation of severe functional impairment that, as a priority, requires continued support from specialised mental health units, psychiatric or social-health care admission; and/or (b) they are unable to determine for themselves (for cognitive reasons or by conscious choice) any problem in at least one occupational area.
early postoperative recurrence in crohn's disease: predictors of research targeting the constitutional mutation of irgm

Conditions: Flammatory Bowel Disease; Crohn's Disease

Summary: crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. this disease, due to its morbidity and mortality, poses a significant public health problem in france. apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. among these factors, the nod2 mutations were first identified. studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with crohn's disease. these mutations observed in atg16 and irgm genes. it has been particularly shown on large patient cohorts,the irgm polymorphism was associated with a progressive disease, with histological severity scores. one of the severity criteria of crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. predictive factors for such recurrence after surgery are not known or not.


Eligibility criteria:
inclusion criteria: * sick in whom endoscopic control six months after surgery is needed to assess the presence and severity of endoscopic recurrence in order to alter the medical management. * persons affiliated to the social security * persons who have signed informed consent exclusion criteria: * patient not affiliated to social security * pregnant women * persons participating in other clinical trials

Keywords: crohn's disease gastrointestinal tract
impact of zinc supplementation on mortality and hospitalizations in children aged 1 months to 23 months

Conditions: Morbidity; Mortality; Diarrhea; Pneumonia

Summary: children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (ifa) alone for a period of one year. the primary outcomes were hospitalizations and deaths during this period.

objective: studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. the impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy. design: randomised double blind trial setting: low to middle socio-economic urban neighbourhoods of north and north-west delhi in india participants: 94359 subjects aged 1 month to 23 months interventions: the subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment. main outcome measures: hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. deaths were ascertained through bimonthly visits to households. results: a third of the total children had low zinc levels (\<60 mg/dl) and one fourth had iron deficiency (haematocrit \<33%) at baseline. the proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. the overall death rates were similar in the two groups. conclusions: the lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. future research should address iron and zinc interaction effects on important functional outcomes.

Eligibility criteria:
inclusion criteria: * age 1 months to 23 months * either sex * resident of study area exclusion criteria: * likely to leave the area during the study period * non consent * temporary exclusion criteria illness requiring hospitalization visible severe wasting. visibly wasted children will be referred to a hospital for treatment. they will be eligible for enrollment only after effective rehabilitation.

Keywords: zinc supplementation hospitalisations children mortality iron folic acid
randomized control study of dermal staples vs subcuticular sutures on postoperative scar after thyroidectomy

Conditions: Thyroidectomy; Pain; Esthetic; Dermal Stapler

Summary: in this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. this is a study to see if there is any difference in pain and esthetics in scar formation of these groups.


Eligibility criteria:
inclusion criteria: * patient who will have thyroid surgery exclusion criteria: 1. done thyroid surgery before 2. done any radiotherapy on neck 3. who needs neck dissection 4. laparoscopic ot robotic surgery 5. under 18 years old or over 70 years old 6. bad general condition, high american society of anesthesiologists (asa) score (over 3) 7. who used immunosuppressive drugs in 6 months 8. breast feeder or pregnancy 9. who disagrees to do this trial
effect of fluid challenge on glycocalyx

Conditions: Anesthesia; Endothelial Dysfunction; Sepsis; Septic Shock; Surgery

Summary: interventional study comparing effect of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused boundary region in sublingual microcirculation.

effect of two regimes of fluid challenge on gcx in patients with sepsis and during elective surgery under general anesthesia. hypothesis to be tested: administration of 500 ml of balanced solution as a bolus impairs gcx more than prolonged administration. the aim of the study: comparison of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery. type of the study: open, randomized, interventional. subjects: part a: patients with sepsis within 48 hours before admission to icu requiring fluid challenge based on clinical or echocardiographic assessment. part b: patients during major elective surgery requiring fluid challenge based on clinical or echocardiographic assessment. sample size calculation (based on expected difference in prb, alpha error i =0,05 and study power = 0,99) = 52 patients. investigators plan enrolment of 60 patients for each part, totally 120 patients. intervention: * 500 ml of balanced crystalloid solution within 5 minutes (group "fast") * 500 ml of balanced crystalloid solution within 30 minutes (group "slow") data to be recorded and analysed: demographics, severity score, fluid response assessment, sublingual microcirculation by sdf imaging will be recorded at time points: baseline, after intervention, after 60 minutes, after 120 minutes, plasma syndecan-1 will be analysed before intervention and 120 minutes thereafter, microcirculatory data and perfused boundary region.

Eligibility criteria:
inclusion criteria: arm a: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm b: age 18-70, asa status i-iii, major surgery exclusion criteria: none.
phase 1 trial of chlorogenic acid in patients with advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.


Eligibility criteria:
inclusion criteria: * advanced cancer with no effective treatment * karnofsky performance status no less than 70 * adequated organ function * informed consent exclusion criteria: * allergic to chlorogenic acid * persistent toxicities from previous treatment (no less than grade 2)

Keywords: no available effective treatment
evaluation of the gtx™ 5126 des coronary stent system in the treatment of patients with a lesion in the coronary artery

Conditions: Coronary Artery Disease

Summary: the gtx™ drug eluting coronary stent system is intended for the treatment of patients with a lesion in the coronary artery.


Eligibility criteria:
key inclusion criteria: * patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease * planned treatment of one lesion with a single stent * denovo type a, b1 lesions with a reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm key exclusion criteria: * diabetic (hba1c \>6.0) * platelet count \ 700000 cells/mm3; wbc \< 3000 cells/mm3; or a hemoglobin \< 10 g/dl * renal dysfunction with creatinine \> 2.0 mg/dl * patient has a known pre-dilatation ejection fraction (ef) less than forty five (\<45%) * myocardial infarction (mi) less than 3 months prior to intervention * patient has type b2, c lesion * reference artery diameter \ 3.6 mm * target lesion length \ 16 mm * other stenosis \>50% in target vessel * known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.
self-management and care of heart failure with group clinics (smac-hf)

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to help people with heart failure (hf) to manage their hf and to prevent rehospitalizations. another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their hf. it is proposed that the group clinic intervention (hfcaregroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.

aim 1 hypothesis: 1. the time to the 1st composite endpoint (hf rehospitalization/death) will be longer for hfcaregroup than standard care group at 12 months. 2. the hfcaregroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months. 3. health services use will be lower in hfcaregroup than standard care group at 12 months. aim 2 hypothesis: 1. the hfcaregroup will have higher score than standard care on patients' hf self-management i.e., self-care behaviors, participation with health care professionals in hf management and problem-solving, hf knowledge and preparedness for home care at 6 and 12 months. 2. a greater proportion of hfcaregroup vs standard care subjects will report clinical or symptoms of hf decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.

Eligibility criteria:
inclusion criteria: * 18 years or older * speak english/spanish * receiving treatment for congestive heart failure * receiving iv diuretics * 2 or more hf symptoms * be able to participate in follow up visits exclusion criteria: * primary right-sided heart failure * hf transient \& related to acute mi * hf due to correctable cause * being scheduled for coronary revascularization or any readmission * receiving infusion for hf therapy within 2 weeks * having co-morbidities, life expectancy \< 12 months * severe cognitive impairment * d/c to nursing facilities or rehab unit * currently enrolled in an intervention study or hf management program * being or planning to become pregnant within 12 months * severe cognitive impairment
investigating accelerated learning in tinnitus participants implanted with vagus nerve stimulation

Conditions: VNS Implanted Tinnitus Patients

Summary: the purpose of this study is to investigate whether it is possible to accelerate learning and improve memory performance in vns implanted tinnitus participants by pairing vns with a verbal paired-associate learning task.

associative memory refers to remembering the association between two items, such as a face and a name or a word in english and the same word in another language. it is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by alzheimer׳s disease. for decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory. vagus nerve stimulation (vns) has been delivered to patient populations (e.g. depression, epilepsy, ...) for more than 25 years and there has been some indications that this technique has effects on cognition, more specifically memory. studies have investigated vns as a way to improve memory performance and it has been shown in some studies to enhance memory in rats and humans. it has also demonstrated to produce changes in the electrophysiological and metabolic profile of forebrain and brainstem structures involved in learning and memory. to investigate whether vns can accelerate learning and improve associative memory when learning word pairs, we will investigate the performance of vns implanted participants on a verbal paired-associate memory task and compare their performance on the words that were learned while paired with vns in contrast to their performance on the words that were learned while unpaired with vns and in contrast to their performance on the words that were learned without vns (i.e. 3 types/groups of words: paired with vns, unpaired with vns and without vns) during the first visit and 1 day,1 week and 1 month after their first visit.

Eligibility criteria:
inclusion criteria: * 18-70 years old * native english speaker exclusion criteria: * acquainted with the foreign language used in the learning task

Keywords: vns accelerate learning memory
immunomodulation effect of regional citrate anticoagulation in acute kidney injury requiring continuous renal replacement therapy

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to study the effect of anticoagulation in immune response with acute kidney injury (aki) undergoing continuous renal replacement therapy (crrt).


Eligibility criteria:
inclusion criteria: * systemic inflammatory response syndrome; sirs \> or = 2 meets definition * patients with acute kidney injury in the intensive care ward. * requiring continuous renal replacement therapy. exclusion criteria: * pregnancy * cirrhosis * end stage renal disease * hiv infection * serum creatinine in male \> 2 mg/dl and female \> 1.5 mg/dl * bleeding

Keywords: acute kidney injury requiring continuous renal replacement therapy